Therapeutic Effect of an Herbal Medicine on Anxiety
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Millet Roux.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Millet Roux
Information provided by:
Millet Roux
ClinicalTrials.gov Identifier:
NCT01178632
First received: August 8, 2010
Last updated: August 9, 2010
Last verified: August 2010
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Purpose
Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders |
Drug: Passiflora Drug: Valeriana officinalis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder |
Resource links provided by NLM:
Further study details as provided by Millet Roux:
Primary Outcome Measures:
- Hamilton anxiety scale score [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
Secondary Outcome Measures:
- Insomnia gravity index [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
- Clinical global impression rate scale and Patient global evaluation rate scale [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.
| Estimated Enrollment: | 136 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Passiflora, Anxiety Disorders
1 tablet Passiflora;Crataegus;Salix; PO;BID
|
Drug: Passiflora
01 tablet Passiflora p.o., b.i.d.
Other Name: PASSIFLORINE
|
|
Active Comparator: Valeriane, Anxiety Disorder
1 tablet Valeriana officinalis, PO, BID
|
Drug: Valeriana officinalis
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
Other Name: VALERIANE
|
Detailed Description:
The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.
The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).
Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of generalized anxiety disorder
- HAM-A scale > 17 and <30
Exclusion Criteria:
- HAM-A scale > 30
- Psychotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178632
Contacts
| Contact: MARIA ELISABETE A MORAES, MD, PhD | 5585-32232903 | betemora@matrix.com.br |
Locations
| Brazil | |
| Clinical Pharmacology Unit - Unifac | Not yet recruiting |
| Fortaleza, Ceara, Brazil, 60430-270 | |
| Principal Investigator: MARIA ELISABETE A MORAES, MD, PhD | |
| Sub-Investigator: ALEXANDRE AQUINO CAMARA, MD | |
Sponsors and Collaborators
Millet Roux
Investigators
| Study Director: | MARIA ELISABETE A MORAES, MD, PhD | CLINICAL PHARMACOLOGY UNIT - UNIFAC |
More Information
Additional Information:
No publications provided
| Responsible Party: | FRANCISCO ALVES BORGES, MILLET ROUX |
| ClinicalTrials.gov Identifier: | NCT01178632 History of Changes |
| Other Study ID Numbers: | MR4009 |
| Study First Received: | August 8, 2010 |
| Last Updated: | August 9, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Millet Roux:
|
Herbal Phytotherapy Passiflora Valeriana Anxiety |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013